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Trial #NCT01985126
Multiple Myeloma Clinical Trials

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD


An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a Proteasome Inhibitor and an IMiD
Study ID: CR102651; Secondary ID: 54767414MMY2002; Source: Janssen Research & Development, LLC
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Active, not recruiting
Country Multiple Countries
Study type Interventional
Enrollment 125
Start date September 2013
Completion date October 2016
Phase Phase 2
Sponsor Janssen Research & Development, LLC
Summary:
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment
regimens in participants with multiple myeloma who have received at least 3 prior lines of
therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are
double refractory to a PI and an IMiD.
Description:
This is an open-label (identity of assigned study drug will be known) study of daratumumab
for the treatment of participants with multiple myeloma who have received at least 3 prior
lines of therapy including a PI and an IMiD or whose disease is double refractory to both a
PI and an IMiD. Up to approximately 150 participants are to be enrolled. The study includes
screening, treatment, and follow-up phases. Participants will receive daratumumab by
intravenous infusion (28-day cycles) until disease progression, unacceptable toxicity, or
other protocol-defined reasons. For all study drug administrations, participants will
receive pre- and post-infusion medications for the prevention of infusion related reactions.
Follow-up will continue until death, loss to follow up, consent withdrawal for study
participation, or study end, whichever occurs first. The study will consist of 2 sequential
parts (Part 1 and Part 2). The purpose of Part 1 is to select a dose and schedule for Part 2
of the study. Assessment of tumor response and disease progression will be conducted
according to IMWG response criteria. Serial pharmacokinetic blood samples and a
pharmacogenomic blood sample will be collected. Safety will be monitored throughout the
study. At the end of the study (18 months after last participant receives first dose of
study drug), participants who are benefiting from treatment with daratumumab will have the
option to continue treatment in Study 54767414MMY2002.
Eligibility:
Gender: Both
Age: 18 Years - N/A
Inclusion Criteria:
- Documented multiple myeloma according to protocol-defined criteria
- Evidence of disease progression on the most recent prior treatment regimen based on International Myeloma Working Group criteria
- Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
- Laboratory values and electrocardiogram within protocol-defined parameters at screening
Exclusion Criteria:
- Received daratumumab or other anti-CD38 therapies previously
- Nonsecretory multiple myeloma
- Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
- Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
- Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Outcome:
Primary outcome
  • Overall response rate following treatment with daratumumab
    Time frame: Up to 6 months after the last participant is enrolled in the study
Secondary outcome
  • Clinical benefit rate following treatment with daratumumab
    Time frame: Up to 8 weeks after the last dose of daratumumab administered
  • Duration of and time to response to daratumumab
    Time frame: Up to 18 months after last participant receives first dose of study drug
  • Maximum observed concentration of daratumumab
    Time frame: Up to post-treatment visit Week 8
  • Minimum observed concentration of daratumumab
    Time frame: Up to post-treatment visit Week 8
  • Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
    Time frame: Up to 30 days after the last dose of study medication
  • Number of participants with antibody-dependent cell-mediated cytotoxicity expression
    Time frame: Up to post-treatment visit Week 8
  • Number of participants with complement inhibitory protein expression
    Time frame: Up to post-treatment visit Week 8
  • Number of participants with complement-dependent cytotoxicity expression
    Time frame: Up to post-treatment visit Week 8
  • Number of participants with generation of antibodies to daratumumab
    Time frame: Up to post-treatment visit Week 8
  • Number of participants with soluble CD38 levels
    Time frame: Up to post-treatment visit Week 8
  • Overall survival following treatment with daratumumab
    Time frame: Up to 18 months after last participant receives first dose of study drug
  • Progression-free survival following treatment with daratumumab
    Time frame: Up to 18 months after last participant receives first dose of study drug
  • Time to disease progression following treatment with daratumumab
    Time frame: Up to 18 months after last participant receives first dose of study drug
  • Total systemic clearance of daratumumab
    Time frame: Up to post-treatment visit Week 8
  • Volume of distribution of daratumumab
    Time frame: Up to post-treatment visit Week 8
Contacts:
  • Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC (Study Director)
Location Country Status
Duarte, California United States
Los Angles, California United States
Atlanta, Georgia United States
Chicago, Illinois United States
Louisville, Kentucky United States
Detroit, Michigan United States
New Brunswick, New Jersey United States
New York, New York United States
Chapel Hill, North Carolina United States
Charlotte, North Carolina United States
Portland, Oregon United States
Philadelphia, Pennsylvania United States
Nashville, Tennessee United States
Houston, Texas United States
Madison, Wisconsin United States
Calgary, Alberta Canada
Edmonton, Alberta Canada
Vancouver, British Columbia Canada
Halifax, Nova Scotia Canada
Montreal, Quebec Canada
Barcelona, Spain
Salamanca N/A, Spain
Valencia, Spain
Sponsors:
  • Janssen Research & Development, LLC - (Lead Sponsor)

Related trials: Terms
  • IMiD
  • Proteasome inhibitor
  • Immunomodulatory drug
  • Daratumumab
  • Multiple myeloma
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